Events

Recall of Accu-Chek Inform II Test. An in vitro diagnostic medical device (IVD)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Roche Diagnostics Australia Pty Limited.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2018-RN-00417-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-05-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00417-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Roche has identified a certain test strip lot that potentially shows an increase in strip errors prior to dosing. due to the designed fail-safe in the blood glucose meter, the issue can be identified by the error message displayed on the meter upon strip insertion or through the device not recognising the test strip, respectively. however, in a limited number of cases the test strip can produce a biased result i.E. a false high or low value, which might not be detected easily and which could lead to erroneous therapy adaptations.
  • Action
    Roche is advising customers to identify affected lot numbers from inventory. If impacted stock is identified users should discontinue using strips immediately and discard. Users should use an alternate unaffected lot to monitor patients' glucose levels.

Device

Accu-Chek Inform II Test. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Accu-Chek Inform II Test. An in vitro diagnostic medical device (IVD)Material Number: 05942861022Lot: Number: 476639ARTG Number: 286479(Roche Diagnostics Australia - Clinical chemistry substrate IVDs)
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited